Lessons from Covid-19
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` LESSONS FROM COVID-19 Advancing Development of Universal Influenza Vaccines Stacey Knobler, Cassidy Howell, Marissa Malchione, Ben McCormick, Alison Mack December 7th, 2020 SABIN VACCINE INSTITUTE 1 TABLE OF CONTENTS Table of Contents ................................................................................................................................... 2 Introduction ............................................................................................................................................. 3 Reckoning with COVID-19 ...................................................................................................................... 3 Disarming a Looming Pandemic ............................................................................................................. 4 Learning from the COVID-19 experience ................................................................................................ 5 Emerging S&T Builds on a Strong Foundation of Fundamental Research ............................................ 6 Collaboration and Information Sharing ................................................................................................. 7 Funding and Investment ..................................................................................................................... 10 Product-focused, End-to-end Development ........................................................................................ 12 Streamlining Regulatory Pathways ..................................................................................................... 13 Ensuring Global Access ..................................................................................................................... 15 Summary and Conclusion ..................................................................................................................... 16 References ........................................................................................................................................... 17 About Sabin .......................................................................................................................................... 23 SABIN VACCINE INSTITUTE 2 INTRODUCTION For the past century, the modern pandemic experience was defined in large part by the global phenomenon of H1N1 influenza in 1918-20 (1)—a model now rapidly being revised, as COVID-19 spreads unchecked across an interconnected world. Despite decades of warnings of the threat posed by emerging infectious diseases (2– 4), humanity has proven tragically underprepared to defend itself against a novel pathogen. As we suffer the consequences of this collective failure of unheeded foresight and imagination, we must seek knowledge that will prepare us to better face future pandemic threats—including the certain emergence of a novel influenza virus (5). RECKONING WITH COVID-19 Identifying and assessing the wide-ranging impacts of COVID-19 on diverse individuals, communities, populations, economic sectors, and systems will require years of scrutiny. Currently available measures of disease burden and socioeconomic disruption paint a grim picture that darkens with each day of uncontrolled disease transmission. At the time of this writing, approximately one year since the emergence of SARS-CoV-2 (the virus that causes COVID-19), the World Health Organization (WHO) reports more than 65 million confirmed cases of COVID-19, and 1.5 million deaths (6). Within the United States, the Centers for Disease Control and Prevention (CDC) reports more than 14 million cases and over 280,000 deaths since January 21, 2020 (7), and forecasts that nearly 330,000 COVID-19 deaths could be reported by the end of the calendar year (8). These numbers vastly underestimate the health burden associated with COVID-19, as indicated by significant excess deaths during 2020 as compared with recent years (9). A combination of an overloaded health systems, along with fear of coronavirus exposure and barriers to care posed by social distancing measures, appear to have reduced uptake of preventive medical care, childhood immunizations (10,11), and diagnosis and treatment of life-threatening conditions, including symptoms of heart attack and stroke (12). The pandemic has also sparked a global mental health crisis (13), as rising rates of anxiety, depression, and suicidal ideation were met with disrupted mental health services (14,15). In October 2020, the International Monetary Fund (IMF) estimated that lost productivity due to COVID-19 would cost the world $28 trillion through the end of 2025, of which $11 trillion would be lost by the end of 2021 (16). Using different methods, cumulative financial costs of the pandemic in the United States alone have been estimated at more than $16 trillion, or about half the nation’s annual gross domestic product (17). However, as Nobel Prize-winning economist Joseph Stiglitz points out, “COVID-19 has not been an equal opportunity virus: it goes after people in poor health and those whose daily lives expose them to greater contact with others. And this means it goes disproportionately after the poor, especially in poor countries and in advanced economies like the United States where access to health care is not guaranteed (18).” Predictably, inequalities exposed and exacerbated by the coronavirus pandemic have sparked social unrest (19). Policy and behavioral responses to COVID-19 have varied widely across the globe and over the course of the pandemic, from the level of national law (20) down to individual perceptions and actions (21,22). “Building the plane while flying it” has become the cliché du jour, as society responds to rapidly evolving epidemiological knowledge of SARS-CoV-2 and its myriad social implications. The rapid and collaborative response by the scientific and medical communities to COVID-19 will surely rank among the most important and effective, and one that is potentially transformative (23–26). Academia, companies of all sizes, philanthropies, governments, and multilateral organizations have joined forces in cooperative enterprises unprecedented in both number and design to confront the pandemic threat (27–32). Information and results—including negative ones—are being shared beyond constraints previously imposed by intellectual property rights and competition for academic or market advancement. Pre-print servers medRxiv and bioRxiv have been flooded with coronavirus research outputs, albeit of varied quality(33), awaiting peer- review; scientific journals are being pressed to provide free access to their contents (34). SABIN VACCINE INSTITUTE 3 The phenomenal scientific response to COVID-19 has already produced a wealth of advancements, including diagnostic methodologies, treatment protocols, therapeutics such as monoclonal antibodies, and hundreds of vaccine candidates representing a range of longstanding and novel technologies. Promising vaccines, developed and tested in record time, not only inspire hope that this pandemic can be extinguished, but that productive changes forced upon the vaccine research and development ecosystem by COVID-19 can be sustained and applied to developing vaccines to avert future pandemics—and in particular, to tackle the persistent health burden and certain pandemic threat of influenza. DISARMING A LOOMING PANDEMIC Devastating as the COVID-19 pandemic has been, and is projected to be, its death toll—now estimated at 1.5 million(6)—is dwarfed by that of the 1918-1920 influenza pandemic, which killed an estimated 50 million people (35). Subsequent flu pandemics in 1957,1968, 1977, and 2009 took between 2 and 4.5 million lives, combined. An influenza virus as deadly as the 1918 strain, which reduced the world’s population by about 3 percent, would today cause more than 230 million deaths. “A worldwide influenza pandemic is literally the worst-case scenario in public health — yet far from an unthinkable occurrence,” warned epidemiologist Michael Osterholm in 2018. “Unless we make changes, the question is not if but when it will come (36).” Meanwhile, every year, seasonal flu costs 300,000 to 600,000 lives and millions of dollars in lost As the COVID-19 experience demonstrates, productivity—despite the existence of influenza time is of the essence in the early stages of a vaccines that, while lifesaving, are far from ideal. To pandemic. Even a heroic vaccine keep up with fast-mutating influenza viruses, flu development effort takes months to bear vaccines are reformulated every year, and are rarely more than 50 percent effective at preventing fruit, while lives and livelihoods are infection. This is perhaps not surprising, since the destroyed. annual vaccine is developed through a laborious process of tracking and predicting which viral strains will prevail. Moreover, more than 90 percent of flu vaccine is produced by egg-based manufacturing, which takes months to complete—during which time a novel influenza strain could easily spread across the globe, killing millions of people (37). Comprehensive protection from influenza necessitates a transition from reactive annual influenza vaccine development to universal influenza vaccines (UIVs): vaccines that provide lifelong or multi-year protection against a broad spectrum of influenza strains (38). Such vaccines would reduce barriers to access in many low- and middle-income countries that currently lack influenza immunization programs due to the expense and logistical difficulties associated with annual vaccination targeting most